The complexity of medical and drug products that we are seeing today are often based on unique and attenuated microbe-based agents that require special handling thus having the BSL-2 program in place enables the CS Analytical Team to assist clients with these unique products in a safe and effective manner
CLIFTON, N.J., Jan. 14, 2025 -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems, is pleased to announce that its New Jersey based laboratory has achieved and been granted Bio-Safety Level – 2 (BSL-2) certification by the United Stated Department of Agriculture. In preparation for the required inspection, the CS Analytical implemented a number of physical improvements and quality system changes that now enable the CSA Team to assist clients when qualification work involves infectious agents or highly level toxic products.
"The complexity of medical and drug products that we are seeing today are often based on unique and attenuated microbe-based agents that require special handling," noted Brandon Zurawlow, Chief Scientific Officer. "having the BSL-2 program in place enables the CS Analytical Team to assist clients with these unique products in a safe and effective manner."
In many cased, BSL-2 labs work with microbes that are associated with human diseases, such as HIV, equine encephalitis viruses, and Staphylococcus aureus (staph infections). As such, a number of safety precautions must be in place inclusive of specialized equipment and chambers in which this type of work can be performed. Other key requirements include:
- Specialized training for all CS Analytical Personnel in the handling of pathogenic agents.
- Laboratory access is restricted when work is being conducted that falls under the BSL-2 requirements.
- When conducting BSL-2 work, personnel wear appropriate PPE, such as lab coats, gloves, eye protection, and face shields.
- The installation and access to equipment that can decontaminate laboratory waste, such as an autoclave.
- Laboratories must have hand washing sinks, eye washing stations, and doors that close automatically and lock.
- Biohazard warning signs must be placed throughout the facility.
Executive Management has continued to implement programs and processes that ensure the CS Analytical Team will always work to meet and exceed client expectations, especially when it comes to critical test needs for unique products and package systems. The team is committed to working with all clients to ensure that the regulatory requirements for their container and package systems continue to meet the strict requirements set forth and expected by the FDA.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world's leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP <1207> services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
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